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Multiparametric Heart Failure Evaluation in Internal Cardioverter Defibrillators (ICD) Patients

NCT ID: NCT01501331

Last Updated: 2014-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2014-11-30

Brief Summary

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The Boston Scientific Energen family is capable of measuring the respiratory rate trend (RRT) on a daily basis and transmission of data via the Remote Monitoring technology. This may result in early detection of imminent decompensation at a presymptomatic stage. The study will assess the respiratory trends correlation with clinically relevant heart failure events.

Detailed Description

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Conditions

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Congestive Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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RRT diagnostic tool

Patients implanted with an Energen device or successor.

CRTD or ICD (Energen)

Intervention Type DEVICE

RRT measurement by cardiac resynchronization therapy devices and implantable cardioverter defibrillators

Interventions

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CRTD or ICD (Energen)

RRT measurement by cardiac resynchronization therapy devices and implantable cardioverter defibrillators

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient eligible for 1-, 2- or 3-chamber ICD implantation according to current guidelines or patient already implanted within the past 45 days with a Energen device or successor
* Able to provide written informed consent

Exclusion Criteria

* Life expectancy \<12 months
* Anticipated non-compliance with the follow-up scheme
* Moderate to severe Chronic Obstructive Pulmonary Disease
* Primary pulmonary hypertension
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Rome Tor Vergata

OTHER

Sponsor Role lead

Responsible Party

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Giovanni B Forleo

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giovanni B Forleo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Rome Tor Vergata

Luca Santini, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Rome Tor Vergata

Locations

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Milan, , Italy

Site Status

Rome, , Italy

Site Status

Countries

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Italy

Other Identifiers

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PTVCARDIO2011_01

Identifier Type: -

Identifier Source: org_study_id